Regulatory Control

1. Purpose

This document provides the process to meet regulatory requirements and covers the process for determining, establishing and maintaining regulatory compliance for ISO13485 and market legislative requirements 

2. Approval

(Version at end of page)

Signed V17 BN 27.10.2025

3. Scope

The process covers all products listed on the SAHPRA licence refer SAHPRA Licence.

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.

4. Responsibilities

Approval: Author of the document, Henry Manyike

Changes: Author of the document, Bonang Ntuli

5. Definitions

Regulatory control are the limitations imposed on the activities of a firm in compliance with the requirements of a regulatory agency e.g. SAHPRA, ISO 13485. 

6. Abbreviations

QMS - Quality Management System

SOP -Standard Operating Procedure

OEM - Original Equipment (Device) Manufacturer (maybe the Producer for a Brand manufacturer e.g. SAP Pharmacy, Dischem)

DoC – Declaration of Conformity

COA – Certificate of Analysis

SAHPRA - South African Health Products Regulatory Authority 

7. References

ISO13485:2016  4.1.1 / 5

www.sahpra.org.za regulations, guidelines and forms

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en 

https://www.fda.gov/medicaldevices/

SOP Management Review

SOP QMS Auditing

SOP Documentation

SOP Non-Conformance Corrective Action

SOP Adverse Incidents & Recall

SOP Change Control

8.Procedure

8.1 Regulatory requirements 

 1.     Relevant country regulatory requirements are located on the website www.sahpra.org.za , also  http://www.sahpra.org.za/acts-and-regulations/ ,  guidance from IMDRF refer website http://www.imdrf.org/documents/documents.asph

Countries; List to be developed [ territory, products listed, applicable legislation, Comments]

2. CE requirements are addressed by the manufacturer refer located http://ec.europa.eu/growth/single-market/european-  standards/harmonised-standards_en for the medical devices, but not limited to,

• Acts and regulations, 

• Licencing guideline and application, 

• Classification, 

• Essential principles, 

• Conformity assessment

3.    The following information should be available from the OEM, where applicable or accessible as required; 

• Medical Device (Technical File), 

• Declaration of conformity, 

• Conformity assessment certification, 

• Regulatory applications

4.    Every quarter a review for compliance to processes and products is required and the QMS Auditing process is followed

5.    Advisory Notices, Vigilance and Adverse Incidents are covered in the Adverse Incident and/or Recall SOP

6.    Regulatory information and documentation will be updated as required from action from the review 6.2 or output of Management Review (SOP) or QMS Auditing (SOP)

7.    Amendments maybe made according to the SAHPRA at https://www.sahpra.org.za/ requirements.  Amendments will be recorded as SOP Documentation

6.    Should regulatory input or reporting be required e.g. Advisory Notices for Adverse Incident and/or Recall SOP is followed

8.2 REGULATORY APPLICATION 

refer Regulatory Drive

8.3 Essential Requirements

4.1.3 For each quality management system process, the organization has established and maintained records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements through the Google Site QMS

4.1.4 The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes are controlled in accordance with the requirements of this International Standard and applicable regulatory requirements as per SOP Change Control

8.3.3 Actions in response to nonconforming product detected after delivery refer SOP Non-conformance Corrective Action

For the organization to document procedures for issuing advisory notices in accordance with applicable regulatory requirements and be capable of being put into effect at any time as per SAHPRA guidelines refer SOP Adverse Incident and/or Recall

 8.4 REGULATORY SCHEDULE

DEPARTMENT OF HEALTH, N0.1515 MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965), REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs); SCHEDULE;

8.5 Responsibilities Definitions

"authorised representative" means a natural person, resident in the Republic of South Africa, who-

(a)      has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic

(b)    acts on behalf of a manufacturer, importer, distributor, wholesaler, retailer or service provider for specified tasks with regard to the latter's obligations and in whose name manufacturer licence, distributor licence, wholesaler licence or certificate of registration is issued; and

(c)      is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration, clinical trials or clinical investigations;

ISO13485:2016 3.2 authorized representative natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation

[SOURCE: GHTF/SG1/N055:2009, 5.2]

EU Article 15 Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

(35) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfills minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

10. REVISION HISTORY

Revision 17, 27.10.2025 - BN - Replaced website link from point 3 wrt SAHPRA Licence as it previously did not work 

Revision 16, 23.02.2024 - BN - Removed website link from point 5 wrt Regulatory Control definition as it did not work 

Revision 15, 18.05.2022 - NT - approval by HM

Revision 14, 16.11.2021 NT - signed off from TNA

Revision 13,  29.09.2021 (TNA) Updating Responsibilities and a few links

Revision 12, 03.02.2021 (TNA) New format with Responsibilities, Risk based approach, Approval and Records added and new google site format.   Amending links and forms

Revision 11; Digitally signed on 16.10.2020 by NT

Revision 1-10, unknown due to google site change to new google site

11. RECORDS

Name                 Retained by/ in Retention period Hard copies Destroyed by

REGULATORY DOCUMENTATION DRIVE folder indefinite         n/a

 LIST OF EXTERNAL DOCUMENTS DRIVE folder indefinite         n/a

SAHPRA / MCC Licence Application Google drive         indefinite  hard copy shredded by Director, 

when amended

SAHPRA / MCC Licence when issued   Google drive indefinite hard copy shredded by Director, when amended

Product Certificates and Technical Files        Principal         indefinite        n/a